A Phase II Study of ACZONE™ (Dapsone) Gel, 5% As a Treatment For Tarceva® (Erlotinib)Related Rash

Stopped early · Phase 2

Conditions studied: Rash, Non-small-Cell Lung Cancer

In brief

The purpose of this study is to evaluate the safety and preliminary efficacy of ACZONE in subjects treated with the HER1/EGFR inhibitor Tarceva (erlotinib) who develop a rash on the face

Key facts

Study ID: NCT00343187
Run by: Allergan
People needed: 2
Starts: 2006-06-01
Expected to finish: 2007-07-01
Last updated by the study team: 2011-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

To be eligible for the study, subjects must fulfill all of the following criteria:
Be male or female ≥18 years of age (inclusive).
Have been prescribed Tarceva as a single agent to treat locally advanced or metastatic NSCLC, after failing at least 1 prior chemotherapy regimen.
Present with acute signs and symptoms of rash on the face that meet the following criteria:
Are suspected to be related to Tarceva,
Include at least 3 inflammatory lesions, and
Are less than CTCAE Grade 3 in severity.
Have an Eastern Co-operative Oncology Group (ECOG) performance status ≤2 and a life expectancy of at least 4 months.
Sign an approved informed consent form for the study.
Be willing to comply with the protocol.

You may not qualify if…

Subjects meeting any of the following criteria will be excluded from the study:
A skin examination reveals the presence of another skin disease and/or condition (excessive facial hair, excessive scarring, sunburn, or other disfigurement) located on the face that, in the study physician's opinion, would confound the evaluation of the rash.
A diagnosis of G6PD deficiency, defined as having a G6PD value below the lower limit of normal.
A diagnosis of anemia, defined as hemoglobin <9.5 g/dL.
Undergoing any current therapy for NSCLC other than Tarceva.
Prior treatment with Iressa, Erbitux, or any experimental HER1/EGFR inhibitor.
Treatment with topical antibiotics, topical steroids, and other topical treatments on the face within 14 days of Day 0 (start of ACZONE/placebo study treatment).
Treatment with any systemic antibiotics within 7 days of Day 0 (start of ACZONE/placebo study treatment).
Treatment with any systemic medication or therapy known to affect anti-inflammatory responses within 30 days prior to Day 0 (start of ACZONE/placebo study treatment). These medications include, but are not limited to, oral corticosteroids, cyclosporine, and methotrexate. Short-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs) before the study for non-rash related conditions is acceptable, provided that exposure is limited to ≤7 days per course. Chronic low-dose aspirin use is also acceptable.
Active participation in an experimental therapy study or received experimental therapy within 30 days of Day 0 (start of ACZONE/placebo study treatment).
A history of hypersensitivity to dapsone, sulfamethoxazole, trimethoprim, parabens, or any component of ACZONE.
A poor medical risk because of other systemic diseases or active uncontrolled infections.
Women who: are lactating; have a positive pregnancy test at Day 0, or; if sexually active and menstruating, are not practicing an adequate method of birth control. Acceptable methods of birth control include intrauterine device (IUD); oral, dermal ("patch"), implanted or injected contraceptives; tubal ligation or hysterectomy (medical documentation required); and/or barrier methods with spermicide. A surgically sterile partner is not considered an adequate method of birth control.

Where it is running

Northwestern University Robert H. Lurie Comprehensive Cancer Center — Chicago, Illinois, United States
Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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